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Hypofractionated Radiation Therapy for Glioblastoma

Study Purpose

Notwithstanding major improvements in treatment modalities, the prognosis of patients with glioblastoma is poor. Hypofractionated radiation therapy as an alternative of the standard 6-week regimen could be an attractive approach as an effort to prevent tumor cell repopulation and reduction the total treatment period promoting patient comfort and convenience.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients 18 to 70 years of age with newly diagnosed and histologically confirmed glioblastoma.
  • - WHO performance status of 2 or less and adequate hematologic, renal, and hepatic function.

Exclusion Criteria:

  • - Prior diagnosis of cancer, unless disease free for > 3 years.
  • - Previous history of radiotherapy in the head and neck region (except initial larynx tumor - T1, T2 / N0M0).
  • - Specific severe, active co-morbidities.
  • - Tumor located in the brainstem.
  • - Presence of leptomeningeal carcinomatosis.
- Multicentric tumor

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03212235
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Instituto do Cancer do Estado de São Paulo
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Unknown status
Countries Brazil
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme
Arms & Interventions

Arms

Experimental: Hypofractionated radiation therapy

Hypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 30-days break, adjuvant temozolomide days 1-5 every 28 days for 6 cycles.

Interventions

Radiation: - Hypofractionated radiation therapy

Hypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

São Paulo, Sao Paulo, Brazil

Status

Recruiting

Address

Instituto do Cancer do Estado de São Paulo (ICESP) - FMUSP

São Paulo, Sao Paulo, 01246-000

Site Contact

Gustavo N Marta, PhD

[email protected]

55+11+38934538